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Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization

Information source: Horizon Health Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Methicillin-resistant Staphylococcus Aureus

Intervention: Rifampin (Drug); Doxycycline (Drug); 2% mupirocin ointment (Other); 4% chlorhexidine gluconate (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Horizon Health Network

Official(s) and/or principal investigator(s):
Duncan Webster, MA, MD, Principal Investigator, Affiliation: Horizon Health Network

Overall contact:
Paula Duffley, RN, Phone: 5066487098, Email: Paula.Duffley@HorizonNB.ca

Summary

MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. As a large number of the investigators patients require re-admission and further transmission may take place in the community, the investigators are comparing the standard decolonization protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory population. Standard decolonization protocols, which use only topical agents, are limited in efficacy. The method of systemic decolonization to be studied here appears to have greater efficacy than the standard approach using only topical agents. However, concerns have been raised that the increased use of systemic antibiotics may lead to increased levels of drug resistance adverse effects, without sustained decolonization. This study seeks to provide further data to help answer these questions and provide guidance for further policy development and implementation.

Clinical Details

Official title: Randomized Controlled Trial of Chlorhexidine Gluconate, Intranasal Mupirocin, Rifampin and Doxycycline Versus Chlorhexidine Gluconate and Intranasal Mupirocin Alone for the Eradication of Methicillin-resistant Staphylococcus Aureus Among an Ambulatory Patient Population

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months

Secondary outcome: Changes in susceptibility patterns of MRSA isolates.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Any patient colonized with MRSA

Exclusion Criteria:

- Currently on treatment with antibiotics

- Pregnant or breastfeeding women

- Active infection

- Hepatic cirrhosis or abnormal INR due to liver disease

- Decolonization in the previous two (2) months

- MRSA bacteria resistant to one or more of the study medications

- AST and ALT levels more than five times the upper limit of normal.

Locations and Contacts

Paula Duffley, RN, Phone: 5066487098, Email: Paula.Duffley@HorizonNB.ca

Saint John Regional Hospital, Saint John, New Brunswick E2L4L2, Canada; Recruiting
Paula Duffley, RN, Phone: 5066487098
Duncan Webster, MA, MD, Principal Investigator
Additional Information

Related publications:

Simor AE, Phillips E, McGeer A, Konvalinka A, Loeb M, Devlin HR, Kiss A. Randomized controlled trial of chlorhexidine gluconate for washing, intranasal mupirocin, and rifampin and doxycycline versus no treatment for the eradication of methicillin-resistant Staphylococcus aureus colonization. Clin Infect Dis. 2007 Jan 15;44(2):178-85. Epub 2006 Dec 14.

Starting date: August 2008
Last updated: August 28, 2013

Page last updated: August 23, 2015

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